Lubricated catheter

ABSTRACT

A catheter assembly for packaging in sterile condition within a protective removable envelope. The catheter assembly includes an elongated rigid body having a longitudinal bore formed therethrough. A catheter is provided and has its distal end slidingly telescoped into one end of the body bore and the body is provided with longitudinal opposite side generally radial slot portions whereby the body is weakened along longitudinal radial planes extending along the slot portions for separation of the body from about the catheter. A tubular lubricant reservoir is provided and includes a first open end and a second closed end in the form of a collapsible bulbous portion. The tubular reservoir has its open end telescoped over the distal end of the catheter and the corresponding end of the longitudinal bore formed through the body. In addition, the body includes opposite side outwardly projecting shield portions adjacent the distal end of the body and which are supported from the latter for separation away from the associated catheter with the body portions to be separated along the aforementioned radial planes.

United States Patent [191 Taniguchi 221 Filed:

[ LUBRICATED CATHETER [76] Inventor: Tokuso Taniguchi, 277 Kaiulani St.,

Hilo, Hawaii 96720 Sept. 17, 1974 [21] Appl. No.: 506,896

Related US. Application Data [63] Continuation-impart of Ser. No. 400,694, Sept. 25,

1973, Pat. No. 3,861,395.

[52] US. Cl 128/349 R; 128/348; 128/350 R; 128/245', 128/221 [51] Int. Cl. A61M 25/00; A61M 7/02 [58] Field of Search 128/349 R, 245, 214.4, 128/350 R, 348, 221; 206/632 R, 63.2 A

[56] References Cited UNITED STATES PATENTS 3,444,860 5/1969 Harrell 128/349 R 3,515,137 6/1970 Santomieri.... 128/214.4 3556194 l/1971 Walck 111 206/631 A 3,592,192 7/1971 Harauteneian... l28/214.4

3,595,230 7/1971 Suyeoka 128/214.4 3,605,752 9/1971 Schlesinger.. 128/349 R 3,677,244 7/1972 Hassinger l 128/214.4 3,766,915 10/1973 Rychlik l28/214.4 3,783,876 1/1974 Dye 128/348 X Primary ExaminerAldrich F. Medbery Attorney, Agent, or Firm-C1arence A. OBrien; Harvey B. Jacobson 5 7 ABSTRACT A catheter assembly for packaging in sterile condition within a protective removable envelope. The catheter assembly includes an elongated rigid body having a longitudinal bore formed therethrough. A catheter is provided and has its distal end slidingly telescoped into one end of the body bore and the body is provided with longitudinal opposite side generally radial slot portions wherebythe body is weakened along longitudinal radial planes extending along the slot portions for separation of the body from about the catheter. A tubular lubricant reservoir is provided and includes a first open end and a second closed end in the form of a collapsible bulbous portion. The tubular reservoir has its open end telescoped over the distal end of the catheter and the corresponding end of the longitudinal bore formed through the body. In addition, the body includes opposite side outwardly projecting shield portions adjacent the distal end of the body and which are supported from the latter for separation away from the associated catheter with the body portions to be separated along the aforementioned radial planes.

10 Claims, 15 Drawing Figures PATENTED AUG 1 2 I975 SHEET Fig. /0

Fig. /2

L ll

l/l/l/ LUBRICATED CATHETER This application comprises a continuation-in-part of my copending US. application Ser. No. 400,694, filed Sept. 25, 1973, and now US. Pat. No. 3,861,395, for Automated Catheter.

BACKGROUND OF THE INVENTION Various types of self-lubricating catheters and catheters specifically designed for sterile packaging have been heretofore designed. Examples of such previously patented catheters may be found in US. Pat. Nos.

3,677,244, 3,682,173, 3,683,928 and 3,776,915. Although these numerous prior types of catheters have been developed, a need still exists for a catheter construction which will lend itself to sterile packaging, ease in lubrication by lubricant also contained within the sterile packaging and ease of insertion by way of a tubular guide through which the catheter is advanced during insertion and which may be readily separated from about the catheter after insertion.

BRIEF DESCRIPTION OF THE INVENTION The automated catheter assembly of the instant invention has been designed to simplify the catheterization of either the male urinary bladder or the female urinary bladder. The automated catheter assembly may utilize substantially any accepted rubber catheter or its equivalent and includes structure whereby the associated catheter may be lubricated in a sterile manner as it is placed in use and inserted into the female urethra or male penis without contamination of the rubber catheter during insertion. Also, the automated catheter assembly is provided with a support body having a bore formed therethrough and the associated catheter is advanced through the bore while one hand supports the body in alignment with the female urethra or the male penis. Also, the body includes opposite side shield portions whereby adjacent portions of the patients body are shielded against contact with the distal end of the catheter and the body and the shield may be readily broken away from the proximal end of the catheter after the latter has been inserted.

The main object of this invention is to provide a catheter assembly designed to simplify the catheterization of male and female patients.

Another object of this invention is to provide a catheter assembly wherein the catheter may be readily lubricated in a sterile state immediately prior to insertion of the distal end of the catheter.

Still another object of this invention, in accordance with the immediately preceding object, is to provide a catheter assembly including shield structure for shielding the distal end of the catheter from contact with parts of the body other than the urethra of a female patient and the penis of a male patient.

Another important object of this invention is to provide an automated catheter assembly in accordance with the preceding objects and which may be used in conjunction with a conventional catheter.

A final object of this invention to be specifically enumerated herein is to provide a catheter assemblage in accordance with the preceding objects and which will conform to conventional forms of manufacture, be of simple construction and easy to use so as to provide a device that will be economically feasible, simple to use and relatively trouble free in operation.

These together with other objects and advantages which will become subsequently apparent reside in the details of construction and operation as more fully hereinafter described and claimed, reference being had to the accompanying drawings forming a part hereof, wherein like numerals refer to like parts throughout.

BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a side elevational viewrof a catheter assembly constructed in accordance with the present invention and adapted to be utilized in catheterizing a male patient;

FIG. 2 is a view of the tubular body and shield portions of the catheter assembly;

FIG. 3 is an enlarged end elevational view of the catheter assembly of the instant invention as seen from the left-hand side of FIG. 1 and prior to lubrication of the catheter;

FIG. 4 is a fragmentary vertical sectional view taken I substantially upon the plane indicated by the section line 4-4 of FIG. 3 and illustrating the manner in which the catheter may be lubricated and the lubricant reservoir may be removed in phantom lines;

FIG. 5 is a vertical sectional view taken substantially upon the plane indicated by the section line 5-5 of FIG. 4;

FIG. 6 is a fragmentary perspective view of the proximal end of the lubricant reservoir;

FIG. 7 is an enlarged fragmentary vertical sectional view taken substantially upon the plane indicated by the section line 77 of FIG. 6;

FIG. 8 is a fragmentary vertical sectional view similar to the central portion of FIG. 4 but illustrating the lubricant reservoir in the process of being endwise telescoped from the distal end of the catheter;

FIG. 9 is a perspective view of the removable spring clamp by which the protective bag portion of the catheter assembly is removably supported from the proximal end of the tubular body portion of the automated catheter;

FIG. 10 is a side elevational view of a catheter assembly constructed in accordance with the present invention and adapted to be utilized in catheterizing a female patient;

FIG. 11 is a fragmentary enlarged top plan view of the distal end of the catheter assembly illustrated in FIG. 10;

FIG. 12 is an enlarged fragmentary longitudinal vertical sectional view taken substantially upon the plane indicated by the section line 12l2 of FIG. 11;

FIG. 13 is a transverse vertical sectional view taken substantially upon the plane indicated by the section line l313 of FIG. 12;

FIG. 14 is an enlarged fragmentary side elevational view of the proximal end of the tubular lubricant reservoir utilized in the assembly illustrated in FIGS. 10 through 13; and

FIG. 15 is a side elevational view of the tubular body and shield portion of the female form of automated catheter with parts thereof being broken away and illustrated in vertical section and an exploded or removed position of the top half of the tubular body illustrated in phantom lines.

DETAILED DESCRIPTION OF THE INVENTION Referring now more specifically to the drawings, the numeral generally designates a catheter assembly for utilization in conjunction with male catheterization. The catheter assembly 10 includes a generally cylindrical body 12 having a longitudinal bore 14 formed therethrough. The body 12 includes a forward or distal end 16 and a rear or proximal end 18 and the forward end of the bore 14 includes a slightly outwardly flaring counterbore 20. Also, an intermediate portion of the body 12 includes an outwardly projecting and circumferentially extending rib 29 for a purpose to be hereinafter more fully set forth.

Formed integrally with the distal end 16 is a generally circular plate 22 and the plate 22 projects radially outwardly from the distal end 16 and closes the rear or proximal end of a forwardly opening cup-shaped shield 24 including a thickened reinforcing bead 26 at its forward distal end.

The body 12, plate 22 and shield 24 are slotted along one radial plane of the coinciding center axes of the bore 14, the counterbore and the shield 24. The diametrically opposite portions of the body 12, the plate 22 and shield 24 are provided with slightly longitudinally spaced slots 30, 32 and 34 with unslotted portions 36 and 38 of the shield 24 and body 12 being disposed between the slots and 32 and the slots 32 and 34. The continuous slot diametrically opposite the slots 30, 32 and 34 is referred to by the reference numeral 40 and portions of the shield 24 closely adjacent the slot 40 are provided with outwardly projecting manually engageable lugs 42 and 44 for a purpose to be hereinafter more fully set forth.

The distal end 46 of a catheter 48 is telescoped through the bore 14 from the proximal end 18 of the body 12 and substantially fully received within the shield 24. In addition, the open end portion 50 of an elongated tubular envelope 52 is telescoped over the proximal end 18 of the body 12 and retained in position thereon by means of a C-shaped spring clamp 54 including a manually engageable lug 56 provided to facilitate manual removal of the spring clamp 54. The opposite end of the tubular envelope or sleeve 52 is closed and fully encloses the proximal end of the catheter 48. However, the opposite end of the sleeve 52 may be left partially open when the proximal end of the catheter 48 is assembled in continuity with a tube (not shown) leading to a drainage bag.

A tubular lubricant reservoir 58 is provided and includes three peripherally spaced and radially outwardly projecting wedge-type lugs60 on its proximal end with the lugs 60 being radially inwardly displaceable through generally radial slots 62 formed in the proximal end of the reservoir 58. The proximal end of the reservoir 58 is tightly wedged into the outwardly flaring counterbore 20 and the distal end of the tubular reservoir is closed by means of a collapsible bulbous portion 64 disposed outwardly of the distal end of the shield 24 and provided with a slotted closure diaphragm 66 at least substantially closing the interior of the bulbous portion 64 from the remainder of the lubricant reservoir 58. A quantity of lubricant 68 is disposed in the bulbous portion 64 behind the slotted diaphragm 66 and the lubricant 68 may be expressed from the bulbous portion 64 through the slotted diaphragm 66 by manually squeezing the bulbous portion 64. Upon expression of lubricant 68 from the bulbous portion 64 through the diaphragm 66, the lubricant passes through the tubular lubricant reservoir 58 about the distal end 46 'of the catheter 48 toward the proximal end of the reservoir 58.

The entire catheter assembly 10 described above in detail is adapted to be sealingly enclosed within a protective envelope for sterile purposes. When it is desired to use the catheter 10, the outer protective envelope is removed and the bulbous portion 64 is manually collapsed in order to express the lubricant 68 from the bulbous portion 64 and cause the distal end 46 of the catheter 48 to be lubricated. Then, the lubricant reservoir 58 is displaced to the left as illustrated in phantom lines in FIG. 4 to withdraw the lubricant reservoir 58 from its frictionally retained but releasable position supported within the slightly outwardly flaring counterbore 20 of the bore 14. Then, the proximal end of the body 12 is gripped through the envelope 52 and the shield 24 is guided over the end of the male penis in order to properly position the distal end 46 of the catheter 48 relative to the male organ. Thereafter, the catheter 48 is pushed forward through the envelope 52 to project the distal end thereof into the male organ while the latter and the shield 24 are held in aligned relation by the other hand and with the shield 24 serving as a docking guide to maintain alignment of the head of the male organ with the distal end 46 of the catheter 48. After the catheter 48 has been pushed forward sufficiently for the distal end 46 thereof to be inserted into the bladder, the clamp 54 is removed from about the open end of the envelope 52 in order that the latter may be slipped from the proximal end of the catheter 48. Then, the lugs 42 and 44 are engaged in both hands and pulled apart in order to split the body 12, the plate 22 and the shield 24 along the slots 30, 32 and 34. Thereafter, the two halves of the assembly 10 are removed from about the catheter 48.

In FIGS. 10 through 15 of the drawings there may be seen a modified form of catheter assembly referred to in general by the reference numeral 10. The assembly 10 is constructed in accordance with the present invention, but is adapted to be used in catheterizing female patients. Various of the components of the female catheter assembly 10 are identical, or at least substantially identical, to corresponding components of the male catheter assembly 10. Accordingly, the various identical or nearly identical components of the female catheter 10 are designated by prime reference numerals corresponding to the numerals applied to the corresponding components of the male catheter illustrated in FIGS. 1 through 9.

The female catheter assembly 10' differs from the male catheter assembly 10 in that the female catheter 10 does not include a shield corresponding to the shield 24. Rather, the lower portion of the tubular body 12 of the female catheter assembly 10 is provided with a depending support rib 13 from whose lower marginal portion a horizontal transverse flange 15 is supported. The opposite side marginal portions of the flange l5 converge forwardly and have upstanding opposite side shield flanges l7 and 19 supported therefrom notched at their forward ends as at 21 and 23, respectively. Also, the flange 19 includes an upwardly projecting handle 25 intermediate its front and rear ends.

In operation, the female catheter assembly is moved into position by one hand, while the labial folds are separated with the other hand, upon insertion of the distal end 46' of the catheter 48 into the urethra. the catheter assembly 10 is grasped by the handle 25, and the catheter 48' is pushed forward through the envelope 52' until the catheter 48 enters the bladder. To free the catheter 48', the entire lower half of the assembly 10 comprising the rib 13, flange l5, flanges l7 and 19 and lower half of the body 12' are broken away from the upper half of the body 12'.

The foregoing is considered as illustrative only of the principles of the invention. Further, since numerous modifications and changes will readily occur to those skilled in the art, it is not desired to limit the invention to the exact construction and operation shown and described, and accordingly all suitable modifications and equivalents may be resorted to, falling within the scope of the invention.

What is claimed as new is as follows:

1. A catheter assembly for packaging in sterile condition within a removable protective envelope, said assembly including an elongated separable body having a longitudinal passageway formed therethrough open at its opposite ends, a catheter having its distal end telescoped into said passageway from one end thereof at one end of said body for subsequent projection of said catheter from the other end of said passageway, said body being provided with, on one side thereof, a longitudinally extending weakened zone and on the opposite side thereof longitudinally spaced and aligned slots, the connecting portions of said opposite side of said body disposed between adjacent ends of adjacent slots and the latter defining a second weakened zone extending longitudinally of said body, whereby said body may be parted along said weakened zones from about said body, and a tubular lubricant reservoir open at one end and having said one end removably telescoped over said distal end of said catheter and within said other end of said passageway, the other end of said tubular reservoir defining a lubricant receiving area and including means operative to cause displacement of said lubricant from said area toward said one end of said tubular reservoir and about said distal end of said catheter.

2. The combination of claim 1 wherein said one end of said body includes an endwise outwardly opening cup-shaped shield into the center of whose closed end said one end of said passageway opens, said shield including weakened opposite side areas thereof aligned with said weakened zones of said body.

3. The combination of claim 1 wherein said one end of said body includes a living body engaging shield.

4. The combination of claim 3 wherein said shield is supported solely from a portion of said body disposed between said weakened zones.

5. The combination of claim 1 wherein said tubular lubricant reservoir is constructed of stiff but somewhat resilient material, said lubricant receiving area comprising a hollow and collapsible bulbous enlargement carried by said other end of said tubular reservoir, said means operative to cause lubricant from said area comprising deformable material of which said bulbous enlargement is constructed.

6. The combination of claim 1 wherein said one end of said tubular lubricant reservoir includes circumferentially spaced lengthwise extending tongue portions supported from the remainder of said reservoir only at the ends thereof adjacent said other end of said reservoir, the outer surfaces of said tongue portions defining wedge surfaces for causing inward displacement of the free ends of said tongue portions in response to seated engagement of said tongue portions in the other end of said passageway.

7. A catheter assembly for packaging in sterile condition within a removable protective envelope, said assembly including an elongated body having a longitudinal passageway formed therethrough open at its opposite ends, a catheter having its distal end telescoped into said passageway from one end thereof at one end of said body for subsequent projection of said catheter from the other end of said passageway, and a tubular lubricant reservoir open at one end and having said one end removably telescoped over said distal end of said catheter and within said other end of said passageway, the other end of. said tubular reservoir defining a lubricant receiving area and including means operative to cause displacement of said lubricant from said area toward said one end of said tubular reservoir and about said distal end of said catheter.

8. The combination of claim 7 wherein said one end of said tubular lubricant reservoir includes circumferentially spaced lengthwise extending tongue portions supported from the remainder of said reservoir only at the ends thereof adjacent said other end of said reservoir, the outer surfaces of said tongue portions defining wedge surfaces for causing inward displacement of the free ends of said tongue portions in response to seated engagement of said tongue portions in the other end of said passageway.

9. The combination of claim 7 wherein said one end of said body includes an endwise outwardly opening cup-shaped shield into the center of whose closed end said one end of said passageway opens, said shield including weakened opposite side areas thereof aligned largement is constructed. 

1. A catheter assembly for packaging in sterile condition within a removable protective envelope, said assembly including an elongated separable body having a longitudinal passageway formed therethrough open at its opposite ends, a catheter having its distal end telescoped into said passageway from one end thereof at one end of said body for subsequent projection of said catheter from the other end of said passageway, said body being provided with, on one side thereof, a longitudinally extending weakened zone and on the opposite side thereof longitudinally spaced and aligned slots, the connecting portions of said opposite side of said body disposed between adjacent ends of adjacent slots and the latter defining a second weakened zone extending longitudinally of said body, whereby said body may be parted along said weakened zones from about said body, and a tubular lubricant reservoir open at one end and having said one end removably telescoped over said distal end of said catheter and within said other end of said passageway, the other end of said tubular reservoir defining a lubricant receiving area and including means operative to cause displacement of said lubricant from said area toward said one end of said tubular reservoir and about said distal end of said catheter.
 2. The combination of claim 1 wherein said one end of said body includes an endwise outwardly opening cup-shaped shield into the center of whose closed end said one end of said passageway opens, said shield including weakened opposite side areas thereof aligned with said weakened zones of said body.
 3. The combination of claim 1 wherein said one end of said body includes a living body engaging shield.
 4. The combination of claim 3 wherein said shield is supported solely from a portion of said body disposed between said weakened zones.
 5. The combination of claim 1 wherein said tubular lubricant reservoir is constructed of stiff but somewhat resilient material, said lubricant receiving area comprising a hollow and collapsible bulbous enlargement carried by said other end of said tubular reservoir, said means operative to cause lubricant from said area comprising deformable material of which said bulbous enlargement is constructed.
 6. The combination of claim 1 wherein said one end of said tubular lubricant reservoir includes circumferentially spaced lengthwise extending tongue portions supported from the remainder of said reservoir only at the ends thereof adjacent said other end of said reservoir, the outer surfaces of said tongue portions defining wedge surfaces for causing inward displacement of the free ends of said tongue portions in response to seated engagement of said tongue portions in the other end of said passageway.
 7. A catheter assembly for packaging in sterile condition within a removable protective envelope, said assembly including an elongated body having a longitudinal passageway formed therethrough open at its opposite ends, a catheter having its distal end telescoped into said passageway from one end thereof at one end of said body for subsequent projection of said catheter from the other end of said passageway, and a tubular lubricant reservoir open at one end and having said one end removably telescoped over said distal end of said catheter and within said other end of said passageway, the other end of said tubular reservoir defining a lubricant receiving area and including means operative to cause displacement of said lubricant from said area toward said one end of said tubular reservoir and about said distal end of said catheter.
 8. The combination of claim 7 wherein said one end of said tubular lubricant reservoir includes circumferentially spaced lengthwise extending tongue portions supported from the remainder of said reservoir only at the ends thEreof adjacent said other end of said reservoir, the outer surfaces of said tongue portions defining wedge surfaces for causing inward displacement of the free ends of said tongue portions in response to seated engagement of said tongue portions in the other end of said passageway.
 9. The combination of claim 7 wherein said one end of said body includes an endwise outwardly opening cup-shaped shield into the center of whose closed end said one end of said passageway opens, said shield including weakened opposite side areas thereof aligned with said weakened zones of said body.
 10. The combination of claim 7 wherein said tubular lubricant reservoir is constructed of stiff but somewhat resilient material, said lubricant receiving areas comprising a hollow and collapsible bulbous enlargement carried by said other end of said tubular reservoir, said means operative to cause lubricant from said area comprising deformable material of which said bulbous enlargement is constructed. 